Ethics in Biomedical Research
(Ethics in Human Experimentation)
Biomedical research involving human
beings is aimed to:
1. Improve diagnostic procedure
2. Improve therapeutic procedure
3. Improve prophylactic procedure
4. Understanding the etiology and
pathogenesis of disease.
Medical advancement is based on medical
research and for conducting research human
subjects are necessary.
At times, medical research may prove
hazardous to the human subjects involved
therein.
In India, all research involving human subjects
should be conducted in accordance with the
guidelines prescribed by Indian Council of
Medical Research (ICMR).
The ICMR guidelines are based on following four
basic ethical principles:
1. Autonomy – respect for the human subject
2. Beneficence
Ethical Aspects of Human
research
In 1984, World Medical Association (WMA) drew up
code of ethics on human experimentation, known as
“Declaration of Helsinki”. As per the
declaration:
Biomedical research involving human subjects
should be done after adequate laboratory and
animal experiments and should be conducted by
scientifically qualified persons
Health of human subject involved in research
should be paramount and responsibility rest with
medical person
In India research should be conducted in accordance
with ICMR guidelines for human research 1995.
ICMR Ethical Guidelines For
Human Research (General
Principles)
1. Principles of essentiality – Whereby the
research is considered absolutely essential after
a due consideration of all factors and options
involved.
2. Principles of voluntariness – research subject
should be told regarding the research, the risk
involved. Informed consent should be obtained.
The person has right to abstain or withdraw from
future or further participation in research.
3. Principles of non-exploitation – the research
subjects should be remunerated for their
involvement. The subjects are entitled for
compensation either through insurance or other
means for all foreseeable or unforeseeable risks.
5. Principles of precaution and risk
minimization. Whereby, due care and
caution is taken at all stages of a
research to ensure that the subjects are
put to minimum risk and generally
benefit from the experiment.
6. Principles of professional competence
– research should be conducted by
competent and qualified persons.
7. Principles of accountability and
transparency : the research experiment
will be conducted in a fair, honest,
8. Principles of maximization of the public interest and
distributive justice : Whereby the research or
experiment and its subsequent applicative use are
conducted and used to benefit all humankind.
9. Principle of institutional arrangement: Researcher to
ensure that all the procedures required to be complied
with and all institutional arrangements required to be
made in respect of the research and its subsequent use
or application are duly made in a transparent manner.
10. Principles of public domain: the research should be
brought into public domain so that its results are
generally made known through scientific and other
publications.
11. Principles of totality and responsibility. Whereby,
the professional and moral responsibility, for the due
observance of all the principles, guidelines and
prescriptions rests with all those involved in conducting
the experiment.
Clinical trial
Preclinical trial
Approval by DCGI, ethical committee
Phase 0 healthy subjects
Phase 1 patients
Phase 2 efficacy
Phase 3 safety
Approval by DCGI, ethical committee (IRB)
Phase 4 adverse drug reaction
Ethical committee
Ethical committee should be registered with
(CDSCO) central drug standard control
organization
7 to 15 members
Lawyer
Layman
Social worker
Subject expert
Head from other institute
Epidemiologist
Member secretary
Functions of ethical
committee
Ethics committees review research
proposals involving human participants and
their data
Monitor studies once they begin
May take part in follow-up actions after the
end of the research
Maintain ethical standards and scientific
merit of research involving human subjects
rights of research participants are
protected
